Running head: DEFENSE STRATEGY: ANTIBIOTIC RESISTANCE

Defense strategy: Antibiotic Resistance and the Clinical Decision on How to Treat the Initial Onset of Acute Sinusitis Christine Williams Graceland University Research Methods and Evidence Based Practice Nurs 5170 Dr. Crigger November 10, 2012

Defense strategy: Antibiotic Resistance and the Clinical Decision on How to Treat the Initial Onset of Acute Sinusitis A majority of doctors visits in primary care settings in the United States are related to upper respiratory-tract infections. In fact, it is the third most common reason to visit a provider in a primary care setting (Young, et al., 2008). Approximately, one third of visits that are seen for complaints of upper respiratory-tract infections are diagnosed with acute rhinosinusitis. Eighty percent of those patients diagnosed will be prescribed antibiotics (Young, et al., 2008). Unfortunately, primary care providers continue to over prescribe antibiotics in

their clinical practice because the inability to differentiate a clinical diagnosis between bacterial and viral sinusitis. Most cases of sinusitis are viral and have the potential to evolve into bacterial infections. The lack of clinical resources, office based diagnostic testing, and cost are the

major contributory factors in the difficulty diagnosing rhinosinutis in the primary care setting (De Sutter, et al., 2002). There are several pathogens that cause sinusitis and URI, the most commonly found in adults are Streptococcus pneumonia and Haemophilus influenzae. The most common pathogen to cause sinusitis and URI in children is Morazella catarrhalis (Falagas, et al., 2008). In recent years, these pathogens have become more antibiotic resistant to penicillin, along with ,other classes of antibiotics presents a major global public health issue (Jacobs, 2000). Over prescribing antibiotics for clinically diagnosed sinusitis and URI have damanaging effects, leading to a increasing prelevance of antibiotic resistance in the United States. Antibiotic resistance can lead to higher rates of morbidity, mortality, and cost throughout the United States and the world (Young, et al., 2008).

According to the Center for Disease control guidelines, the recommendation for adult appropriate antibiotic use in treating rhinosinusitis, antibiotic should be considered after symptoms present for 7-10 days (CDC, accessed Oct. 2012). As practitioners and providers, it is difficult to clinically diagnosis acute rhinosinusitis in the office setting. The best evidence and clinical decisions are supported by EBP to assist providers in making a safe practice changes. The questions is, what is the most effective treatment, the use of antibiotic treatment(amoxicillin) or treating symptomatically (placebo) to produce reduced symptoms and improve patient recovery? The purpose of this paper is to investigate whether or not to prescribe antibiotics (amoxicillin) for treating acute sinusitis. PICO: In patients diagnosis with acute sinusitis (P), what is the effect of antibiotic treatment (I) on reducing symptoms and improving patient recovery (O) compared with patients treated with a placebo (C)? Evidence Investigation Selection Criteria During the selection process, time was spent at a local clinic following a Family Nurse Practitioner observing clinical issues in treatment and intervention. The PICO question was then formulated and clinical problem was identified. Consideration was then given to the types of evidence to be collected. The decision was made to utilize the highest level of evidence available, within 5 to 10 years that reflected the clinical problem and PICO question under investigation. The articles were to be strongest in results, valid, and reliable. The selection of evidence would be taken from article that achieved a level rating of Level I and Level II on the Evidence Hierarchy of Designs, which included systematic reviews, meta-analyses and randomized controlled clinical trials. Search Process

The search process started with a comprehensive review of medical literature using the following databases: CINAHL, PubMed, and Google Scholar. The priority was to obtain evidence in articles that were one of the following: Systematic Reviews, Meta- Analysis, and Randomized Controlled Trials at Level I or II on the Evidence Hierarchy of Design. Keyword MESH terms used in searching data was acute sinusitis or rhinosinusitis with subheadings: sinusitis AND treatment AND antibiotic AND amoxicillin AND placebo AND recovery AND symptoms AND rhinosinusitis. MESH terms were chosen to represent population, variables of interest and outcome. Limits that were used included 5years and then 10 years, humans, randomized control trial, meta-analysis, clinical trials, and English. The term amoxicillin was used because this antibiotic is the first line of treatment in antibiotic therapy for acute rhinosinusitis post 7-10 days of persistent symptoms recommended by the CDC, yielding more specific results for intervention in RCTs. PubMed search was done using 5 year and 10 years yielding adequate evidence that was relevant to support the PICO question. Then, the same search was done in CINAHL using the same MESH terms yielding 28 articles, some being duplicated in the search. A Google Scholar search was done for meta-analysis using the terms antibiotic verses placebo in treatment of sinusitis yielding 1 applicable article to support the clinical problem and the question. Finally, a search was done on the CDC website Get Smart for guideline for treatment recommendations for acute rhinosinusitis. The comprehensive review of medical literature from PubMed, CINAHL, and Google Scholar yielded a total of 41 articles of evidence most recent and relevant the clinical problem and PICO question. Selection of Best Evidence

Originally, eight studies were chosen for best evidence, and then with the process of elimination left only five studies chosen as best evidence from the 41 articles searched. These five studies were considered the strongest and most recent evidence accessible at the time of the search that matched the clinical problem and the PICO question. All studies chosen were conducted between 2002 and 2012. Three studies were within five years and two studies were within ten years that was accepted as strongest best evidence for the clinical problem and question. All excluded studies did not reflect the intervention of treatment and measured outcome for the PICO question presented and failed to meet selection criteria. One RCT level II article use CRP as an intervention(point of care) and a control group without CRP, which was not the focus of intervention in either clinical problem or PICO question. CRP was being used as a diagnostic tool for bacterial sinusitis, as inclusion/exclusion criteria and for measuring patient satisfaction with treatment. One article was deleted because of its location, studies were selected to represent a United States clinical problem in relation to the United States CDC guidelines. The final selected studies include: Bucher, Tschudi, Young, Periat, Welge-Lussen, & Zust (2003), Placebo-Controlled, Double-blind, Randomized Trial, level II rating; De Sutter, De Meyere, Christiaens, van Driel, Peersman, & Maeseneer (2002), Pragmatic Randomized Doubleblind Controlled Trial, level II rating; Falagas, Giannopoulou, Vardakas, Dimopoulos, & Karageorgopoulos (2008), Meta-Analysis of Randomized Controlled Trials, level I rating; Garbutt, Banister, Spitznagel, & Piccirillo (2012), Randomized Controlled Trial, level II rating; Young, De Sutter, Merenstein, vanDssen, Kaiser, Varonen, . . . & Bucher (2008), Meta-Analysis, level I rating. Refer to Appendix A matrix for a summary of each selected study of evidence. Critical Appraisal of Collective Evidence

There were five studies selected (2 Meta-Analysis, 3 Randomized Control Trials). Refer to Appendix B for the critique of each selected study for evidence. All of the selected five studies demonstrated adequate sample sizes collectively ranging from 252 to 3,291. The inclusion and exclusion criteria for all selected studies were similar or the same. All studies used strict clinical criteria for inclusion and exclusion, not as diagnostic criteria to determine patient diagnosis of viral verses bacterial sinusitis. Several tests such as C reactive protein, radiological, microbiological, cultures, and rhinoscopy were preformed prior to assignment and for evaluation of adequate samples assuring homogeneous sampling. There was none or minimal bias displayed in the inclusion and exclusion criteria used for the sampling selection. All participants in the studies were representative of the studies populations. According to Polit, sampling bias refers to the under or over representation of a representative population on a characteristic relative to the population of interest addressed in the question (2011). There is minimal bias represented in all chosen studies related to strict controls in the acceptance of participants through the inclusion and exclusion criteria, as well the use of randomization in assignment and double blind interventions allocated to each group. In random allocation each participant is assigned to an intervention or condition at random, giving all an equal chance of being assigned to the groups and eliminating systematic bias that could affect the outcome (Polit, 2012). In all five studies selected there were two type of evidence represented and appropriate the PICO question. All studies evaluated the effectiveness of an antibiotic or placebo in the treatment of patients with acute sinusitis for resolving symptoms and improving recovery. According to Melnyk & Fineout-Overholt (2011), randomized control trials and the strongest evidence with respects to testing a cause and effect relationship, a true experiment. The

second type of evidence used in the selected studies is a Meta-analysis, which is a summary of multiple studies and evaluated with a quantitative method using statistics to represent the effect of the common intervention throughout and across those multiple studies evaluated (Melnyk, 2011). All result reported by the selected studies are within the last ten year and can apply to current clinical practice. All report validates the recommendation of the CDC to treat acute rhinosinusitis. The two meta-analysis (one including 17 RCTs and one includes 2547 individual patient data) were conducted within the last four years providing strong evidence to support the presented PICO question. Four of the studies present results the there is no statistical evidence to support the use of antibiotics in the treatment of acute sinusitis within a 7-10 day of onset of symptoms. One of the four RCT state, that amoxicillin shows a statistical significance in improvement of symptoms on day 7(Garbutt, Banister, Spitznagel, & Piccirillo, 2012). The conclusion was drawn that the statistical significance is too small to impact clinical practices. Therefore, all five studies selected represent a clinical significance in practice with regards that antibiotic treatment makes no difference in comparison to a placebo in resolving symptoms and improving recovery. All five studies selected are consistent reporting that same results of no differences in treatment, improvement, or resolving of symptoms between using an antibiotic or a placebo for treatment. The similarities in the studies in comparison to the PICO question include: population (patient with acute sinusitis), intervention (antibiotic treatment), comparison (placebo treatment), and outcomes (reducing symptoms or improving recovery) confirms the correlation and validity the collective results of the studies have to the EBP question. Further studies are needed to identify the characteristics of the population to differentiate the patients who are more likely to suffer

from bacterial infections and would benefit from antibiotic treatment (Falagas, Giannopoulou, Vardakas, Dimopoulos, & Karageorgopoulos, 2008).

Appendix A PICOT question: In patients diagnosis with acute sinusitis (P), what is the effect of antibiotic treatment (I) on reducing symptoms and improving patient recovery (O) compared with patients treated with a placebo (C) within a 7 to 10 day period (T)? Table 1 A- Summary of Randomized Controlled Trials
Author, Year, Title, Design/Type & Level of Evidence Study Purpose Population Investigate d/ Sample Size Intervention/Co mparison & Outcomes
(Independent/Dependent Variables)

Results with Statistics

Effect of To evaluate Anoxicillinthe Clavulanate in effective Clinically ness of Diagnosed Acute Amoxici Rhinosinusitis: A llinPlaceboClavulan Controlled, ate on Double-blind, adults Randomized Trial with in General acute Practice. rhinosin (Bucher, et al., usitis 2003). clinicall Method: y Dx in Randomized a general controlled trial. practice Double-blind, setting. placebocontrolled.(level 2)

Patients clinically diagnosed with acute rhinosinusitis. 252 adult participants, (125 amoxicillinClavulanate, 127 placebo) 249 completed the trial (day 28) All subjects used one or more symptomatic treatments.

IV= Amoxicillin(ant ibiotic tx) DV= to reduce symptoms and improve patient recovery

No difference was found in the time to cure between the amoxicillin-clavulanate and placebo groups. No statistically significant difference between groups in the mean days of restricted activities at home or work due to rhinosinusitis. Diarrhea at day 7-14 was higher in the amoxicillin group than the placebo. Other adverse effects caused by the amoxicillin group odds ratios were not statistically significant. Hazard ratios were appropriate effect of amoxicillin-clavulanate was 0.99(95%CI, 0.68-1.45 on time to cure and 1.28(95%CI, 0.8002.05) placebo group, all with a positive rhinoscopy result. Mean difference at 7days between groups were -0.29 (95%CI, -0.93 to 0.34) in number of days with restrictions due to rhinosinusitis and -0.60(95% CI, -1.41 to 0.21) in patients with a positive rhinoscopy result. After 7 days amoxicillin was more likely to cause diarrhea(odds ratio, 3.89; 95%CI, 2.09-7.25).

Does Amoxicillim To compare Improve Outcomes the in Patients with efficacy Purulent of Rhinorrhea? A amoxicil Pragmatic lin vs Randomized placebo Double-blind in Controlled Trial in patients Family Practice. with an (De Sutter, et al., acute 2002) upper respirato Method: Doublery tract blind randomized infection placebo-controlled and trail. (level 2) purulent rhinorrh ea. Purpose: to investigate the benefits of antibiotic therapy in a larger group of patients with nose or sinus infections, thereby making the results more widely applicable.

Pt. Dx with URTI and purulent rhinorrhea. N=416, (end total participant s completin g trial n= 374) randomize d patients; n=207 assigned pt. to amoxicilli n group with 5 excluded and 15 withdrawa ls totaling n=187 on day 10 follow up. n=209 patients in the Control group with no treatment with antibiotics, 3 excluded and 19 withdrawals totaling n=187 on day 10 follow up. All subjects

IV= Amoxicillin(ant ibiotic tx) DV= to reduce symptoms and improve patient recovery

No advantage with antibiotic treatment with amoxicillinclavulanate in adult patient of a general practice and more likely to experience adverse effects. There was no statistically significance between groups in in cured patients even though more patients were cured in the amoxicillin group. Although 35% of patients in the amoxicillin group (59/170) therapy was successful compared to the control group at 29% (47/164). RR of success was 1.14(95%CI, 0.92-1.42, P=.24). No effect on duration of general illness or pain. Purulent rhinorrhea was shortened in the amoxicillin group 9 vs 14 days for clearing of purulent rhinorrhea in 75% of patients; P=.007. Diarrhea was more frequent in the amoxicillin group (29% vs. 19% control group, RR= 1.28, 95%CI, 1.05-1.57). No complications were reported. Note 8 patients discontinued the trial r/t exacerbation of symptoms and recovered with antibiotic therapy (RR= 0.25, 95%CI, 0.04-1.56, P=0.07). The chance of antibiotic therapy at day 10 follow up or returning r/t persistent complaints a day 15 was not significantly different between treatment groups (chi sq test: P=.46, and P= .26) Restrictions or absence from work or school were comparable in both groups (RR 0.95, 95%CI, 0.861.05, P= 0.34).

used one or more symptomatic treatments.

Conclusion: Amoxicillin has beneficial effect on purulent rhinorrhea caused by acute infection of the nose or sinuses, but not on general recovery. Pts. can safely be treated with symptomatic therapy.

Amoxicillin for Acute Rhinosinusitis: A Randomized Controlled Trial. (Garbutt, et al., 2012) Method: Randomized, placebo-controlled trial. (level 2)

To determine the increme ntal effect of amoxicil lin treatmen t over sympto matic treatmen ts for adults with clinicall y diagnose d acute rhinosin usitis.

Adults Dx with uncomplic ated acute rhinosinus itis. n=166 adult patients (n=85 randomize d to receive amoxicilli n, n=81 randomize d to receive placebo) After a full 28 day trial (n=81 amoxicilli n group; n=74 placebo group) All subjects used one or more symptomatic treatments.

IV= Amoxicillin(ant ibiotic tx) DV= to reduce symptoms and improve patient recovery

Disease-specific quality of life: The mean change in SNOT-16 was similar in both groups at day 3 (amoxicillin group: 0.59 [95% CI, 0.47- 0.71]; control group: 0.54 [95% CI, 0.410.67], p= .69; mean difference between groups, 0.03 [95% CI, -0.12 0.19]) and at day 10 (mean difference between group, 0.01 [95% CI, -0.130.15]. but differed at day 7, favoring amoxicillin (mean difference between groups of 0.19 [95% CI, 0.024- 0.35]). Days missed from work or unable to perform usual activities, rates of relapse and recurrence by 28days additional health care use, and satisfaction with treatment did not differ by study groups. Telephone calls to the MD (5% for amoxicillin group and 10% for control group; P=.35) and additional office visits (2% for amoxicillin group and 4% for control group; P=.66). No statistically significant difference in reported symptom improvement at day 3 (37% amoxicillin group vs. 34% control group; P= 0.67) or on day 10 (78% amoxicillin group vs. 80% control group, P=0.71), although on day 7 more patients in the amoxicillin group reported symptom improvement (74% amoxicillin group vs. 56% control group, P=0.02). ). No adverse events occurred. The only symptom that predicted benefit with antibiotic treatment at 7 day was nasal obstruction (n=83)

the odds of improvement by day 7 with antibiotic treatment vs. placebo was 4.59 (95% CI, 1.16-18.12) with no benefit in the group without obstruction. Conclusion: Patients Dx with acute rhinosinusitis given a 10 days course of antibiotics compared to a placebo there was no difference in reducing symptoms at day 3 of treatment

Table 1 B- Summary of Meta-Analysis

Author, Year, Title, Design/Type & Level of Evidence Study Purpos e Population Investigat ed/ Sample Size Intervention/ Compari son & Outcome s
(Independent/Depen dent Variables)

Results with Statistics

Comparison of antibiotics with placebo for treatment of acute sinusitis: a metaanalysis of randomised controlled trials. (Falagas, et al., 2008). Method: Metaanalysis of randomized controlled trials.

To assess the therap eutic role of antibio tics for acute sinusiti s compa red with placeb o. To evaluate existing best evidence (RCTs) of therapeutic benefit of antibiotic Tx vs. placebo in Tx acute sinusitis.

Adult patients with clinically diagnosed acute sinusitis. 17 doubleblind RCTs (3 including children)9RCTsDx. With clinical criteria, 6 RCTs Dx with imaging criteria, and 2 RCTs using Dx. Microbiologic al or lab methods criteria. Amoxicillin used in 10 of 23 antibiotic treatment groups. Total outpatient participants 3291 (2915 adults and 376 children) were randomly assigned to receive study treatments in the RCTs or clinical trial

IV= Amoxicillin( antibiotic tx) DV= to reduce symptoms and improve patient recovery (Therapeutic benefit)

The use of antibiotics for acute sinusitis confers a small therapeutic benefit over placebo with a corresponding rise in the risk of adverse events. Recommendation is that antibiotics should be reserved for carefully selected patients with a higher probability for bacterial disease. Meta-analysis results that cure or improvement of pts. with acute sinusitis within a timeframe of 7-15 days from the initiation of treatment was more likely with antibiotic treatment than with placebo. No significant differences were detected in the comparisons between different subgroups of pts. No differences were shown between antibiotic and placebo treatment with regard to disease complications and recurrence. Antibiotic treatment is associated with a higher number of pts. experiencing adverse events than the placebo groups. In comparison with the placebo groups in the selected RCTs, antibiotics were associated with higher rate of cure or improvement (2648 pts., odds ratio OR 1.64, 95%CI,1.352.00), data from 16 trials, or cure alone (1813 pts., OR 1.82, 1.34-2.46) in 12 RCT trials, but also with more adverse events (1963 pts., OR 1.87, 1.21-2.90)

selected in the meta-analysis.

in 12 RCTs. The rate of symptoms resolved faster with antibiotic treatment in most of the selected RCTs.

Antibiotics for -To Patients with adults with evaluat clinically clinically diagnosed e best diagnose acute rhinosinusitis: eviden d acute a meta-analysis of ce rhinosinu individual patient availab sitis. data. le in (Young, et al., RCTs. 2008). in Individual assessi patients data Method: Metang the from 2547 analysis of whethe adults in 9 individual patient r RCTs were data in RTCs. comm checked and on reanalyzed. signs and sympt oms can be used to identif ya subgro up of patient s who benefit from antibio tic treatm ent for acute rhinosi nusitis. -To assess

IV= Amoxicillin( antibiotic Tx.) DV= to reduce sympto ms and improve patient recovery

Common clinical signs and symptoms cannot identify patients with rhinosinusitis for whom treatment is clearly justified. Antibiotics are no justified even if a patient reports symptoms for longer than 7-10 days. The overall treatment effect of antibiotics compared to placebo for estimated OR was 1.35 (95%CI, 1.15-1.59). The variance of random Tx. effects was 0, therefore I2, the measure of heterogeneity was also 0. The exclusion of on trial pt. data remained unchanged (OR 1.36, 1.151.61). The analysis of individual patients data, the estimated OR for the overall treatment effect was 1.37 (95%CI, 1.13-1.66). The mean NNT for 10000 simulated new patients was 15(95%CI, NNT benefit 7 to NNT harm 190), therefore it implies that for every 15 pts. had to be given antibiotics before one additional pt. was cured. The meta-analysis for these trials gave data risk difference, a mean NNT of 14 (95%CI, NNT benefit 9 to NNT benefit 30). In 9 trial reviewed the treatment effect was almost independent of the underlying risk. Pts. with the lowest cure rates were estimated to have a 32% probability of cure without Tx. New patients simulated with this degree of risk had a mean NNT13 (95%CI, NNT benefit 5 to NNT harm 100). Pts. of the trial with the

the overall effect of antibiotic treatment and the prognostic value of common signs and symptoms by the number needed to treat (NNT) with antibiotics to cure one additional patient. Appendix B

highest cure rates were estimated to have a probability of 71% of a cure without Tx. New pts. simulated with this degree of risk had a mean NNT of 18(95%CI, NNT benefit 8 to NNT harm 70).

Single Quantitative Study (e.g., Randomized Controlled Trial, Nonrandomized Controlled Trial, CaseControl Study, Cohort Study) Template Citation (APA) Title Database Source (& ID number) Type of Evidence Hierarchical Evidence Rating Level (Bucher, et al., 2003) Effect of Anoxicillin-Clavulanate in Clinically Diagnosed Acute Rhinosinusitis: A Placebo-Controlled, Double-blind, Randomized Trial in General Practice PubMed (PMID: 12912714) Randomized Controlled Trial Level II on

Your Summary of the Study/Publication (use paraphrasing, not quotes) What was the stated research question/objective To evaluate the effectiveness of Amoxicillin-Clavulanate of the study? adults with acute rhinosinusitis clinically Dx in a general What research methodology was used (e.g., RCT, Case-Control, Cohort)? Describe the sample (including size)?

How was the sample selected (e.g., randomization, inclusion/exclusion criteria)?

practice setting. Randomized controlled trial. Double-blind, placebocontrolled.(level 2) 252 adult participants clinically diagnosed with acute rhinosinusitis, (125 amoxicillin- Clavulanate, 127 placebo) 249 completed the trial (day 28) Stratified randomization and patients were randomized in blocks of 6. A computer random-number generator was used. Inclusion criteria: history of repeated purulent nasal discharge and maxillary or frontal unilateral or bilateral pain for a least

What methods were used for data analysis?

What were the results of the study? At what Level of Significance?

What conclusions/implications for practice were drawn by the authors?

48 hours but less than 1 month and presence of pus under rhinoscopy. Exclusion criteria: younger than 18 years of age, an upper respiratory tract infection or use of antibiotics for any reason within the previous 4 weeks, an upper respiratory tract infection or intermittent fever that persisted for more than 4 weeks, pathologic features or malformation of nasal cavities or the pharynx, immunosuppressive treatment, human immunodeficiency virus infection, allergy to amoxicillinclavulanate, pregnancy or breastfeeding, or no fluency in one of the national languages. After sample was recruited a CRP was performed on all patients, CRP >100 were excluded from the trial, pt with CRP 50-99mg/L were reassessed in 3 days and elevation of CRP > 100 excluded the patient from the trial. Pts. were recruited during the 4 winter seasons(11/1 to 4/30)of 1997 to 2001 from 24 general practices and two outpatient clinics. Three regression methods used: Cox proportional hazards regression for time to cure, linear regression for the number of days with restrictions due to rhinosinusitis, and logistic regression for the proportion of patients with anticipated adverse effects. Statistical analysis was performed using SAS statistical software version 8.02. All CIs were given were 2 sided. No level of significance was stated. All results reported a CI 95%. No difference was found in the time to cure between the amoxicillin-clavulanate and placebo groups. No statistically significant difference between groups in the mean days of restricted activities at home or work due to rhinosinusitis. Diarrhea at day 7-14 was higher in the amoxicillin group than the placebo. Other adverse effects caused by the amoxicillin group odds ratios were not statistically significant. Hazard ratios were appropriate effect of amoxicillin-clavulanate was 0.99(95%CI, 0.681.45 on time to cure and 1.28(95%CI, 0.8002.05) placebo group, all with a positive rhinoscopy result. Mean difference at 7days between groups were -0.29 (95%CI, -0.93 to 0.34) in number of days with restrictions due to rhinosinusitis and -0.60(95% CI, -1.41 to 0.21) in patients with a positive rhinoscopy result. After 7 days amoxicillin was more likely to cause diarrhea(odds ratio, 3.89; 95%CI, 2.09-7.25). No advantage with antibiotic treatment with amoxicillinclavulanate in adult patient of a general practice and more likely to experience adverse effects. The authors states that this study used different diagnostic criteria to identify patient with bacterial acute rhinosinusitis,

there was no difference in improvement of symptoms or cure rates with prescribing antibiotics. The treatment with amoxicillin-clavulanate offers no benefit for adults with acute rhinosinusitis. There is a low availability of diagnostic workup and resources with general practices in which most patients with acute rhinosinusitis are seen, mostly related to cost. The decision to treat with antibiotics is then based on clinical diagnostic criteria, patient history, and physician or patient preference. Further studies are needed using better diagnostic tests to differentiate viral and bacterial acute rhinosinusitis. The authors suggests, a refined symptom score to identify sever cases of acute rhinosinusitis and prolonged URI.
Your Critical Appraisal of the Studys Appropriateness for Application to Clinical Practice Was the research design appropriate for the The research design (randomized controlled trial,double-blind, research question (e.g., RCT for cause-effect placebo-controlled) was appropriate for answering cause and questions, Case Control for harm or causation effect question or intervention/effectiveness question. This questions, Cohort for questions regarding study being level 2 in the evidence hierarchy and an prognosis)? Support your response.

Was the sample size adequate? Was bias controlled with sample selection methods? Support your responses.

appropriate design was included in meta-analysis (Young, et al., 2008) which is a level 1 providing best evidence. Yes, the sample size was adequate and meet the power and required sample size prejected. Estimated: type 1 error of .05 (2 sided), a power of 90%, and an estimated 10% dropout rate , the required sample size 252. All study physicians and the study nurses were blinded to the treatment given to each patient to avoid biasing of data results. Randomization and block design employed to control bias. No level of significance was stated. The study results were no statistically significant utilize antibiotic treatment in pts. with acute rhinosinisitis. However this study is clinically significant for the EBP question in regards to limiting antibiotic use and no differences in treatment r/t placebo and antibiotics for acute sinusitis with presentation of symptoms upto 7-10 days. The results are valid and reliable with CI 95%. There are no confounding variables that can introduce bias with regard to patient present with s/s of acute rhinosinusitis and diagnostic testing done on all participants in the study to monitor the effectiveness of suspected acute bacterial rhinosinusitis. The inclusion and exclusion criteria limited bias and confounding variables with the population of acute rhinosinusitis patients. The finding of this study directly support my EBP question in terms of population (pts. Dx with acute sinusitis) and the intervention (antibiotic treatment). The findinsg are clinically significant in terms of evidence with no difference between antibiotic treatment and placebo in treating the patient with acute rhinsinusitis.

Were the study results significant (level of significance)? Are the results valid and reliable? Is there a possibility of bias or of confounding variables? Support your responses.

Is the study and its findings directly applicable to your EBP question (match all selection criteria)? Support your response.

Single Quantitative Study (e.g., Randomized Controlled Trial, Nonrandomized Controlled Trial, CaseControl Study, Cohort Study) Template Citation (APA) Title Database Source (& ID number) Type of Evidence Hierarchical Evidence Rating Level (De Sutter, et al., 2002) Does Amoxicillim Improve Outcomes in Patients with Purulent Rhinorrhea? A Pragmatic Randomized Double-blind Controlled Trial in Family Practice. PubMed (PMID: 11978253) Randomized Double-blind Controlled Trial Level II

Your Summary of the Study/Publication (use paraphrasing, not quotes) What was the stated research question/objective To compare the efficacy of amoxicillin vs placebo in patients of the study? with an acute upper respiratory tract infection and purulent

rhinorrhea.
What research methodology was used (e.g., RCT, Case-Control, Cohort)? Describe the sample (including size)?

Double-blind randomized placebo-controlled trail. (level 2) Pt. Dx with URTI and purulent rhinorrhea. N=416, (end total participants completing trial n= 374) randomized patients; n=207 assigned pt. to amoxicillin group with 5 excluded and 15 withdrawals totaling n=187 on day 10 follow up. n=209 patients in the Control group with no treatment with antibiotics, 3 excluded and 19 withdrawals totaling n=187 on day 10 follow up. The sample was selected from 69 family practices meeting

How was the sample selected (e.g.,

randomization, inclusion/exclusion criteria)?

What methods were used for data analysis?

What were the results of the study? At what Level of Significance?

inclusion criteria that participants were 12years or older, presenting with acute upper respiratory complaints, and having a history of purulent rhinorrhea and no signs of complications of sinusitis. Exclusion criteria was allergy to penicillin or ampicillin; having received antibiotic therapy within the previous week; complaints lasting for more than 30 days; abnormality on clinical chest examination; complications of sinusitis (facial edema or cellulitis; orbital, visual, meningeal or cerebral signs); pregnancy or lactation; comorbidity that might impair immune competence; and inability to follow the protocol because of language or mental problems. Groups were random assigned with a computer-generated random number list to receive 500mg amoxicillin 3 times a day or placebo for 10 days. Analyzed with SPSS7, Chi square test, Kaplan-Meier survival plots, Log rank test, continuous variables tested by students t test or the nonparametric Mann-Whitney U test. There was no statistically significance between groups in in cured patients even though more patients were cured in the amoxicillin group. No significance level was stated. All results reported a p>0.05 except for purulent rhinorrhea was shortened with amoxicillin in 75% of pts. p=0.07. Although, 35% of patients in the amoxicillin group (59/170) therapy was successful compared to the control group at 29% (47/164). RR of success was 1.14(95%CI, 0.92-1.42, P=.24). No effect on duration of general illness or pain. Purulent rhinorrhea was shortened in the amoxicillin group 9 vs 14 days for clearing of purulent rhinorrhea in 75% of patients; P=.007. Diarrhea was more frequent in the amoxicillin group (29% vs. 19% control group, RR= 1.28, 95%CI, 1.05-1.57). No complications were reported. Note 8 patients discontinued the trial r/t exacerbation of symptoms and recovered with antibiotic therapy (RR= 0.25, 95%CI, 0.04-1.56, P=0.07). The chance of antibiotic therapy at day 10 follow up or returning r/t persistent complaints a day 15 was not significantly different between treatment groups (chi sq test: P=.46, and P= .26) Restrictions or absence from work or school were comparable in both groups (RR 0.95, 95%CI, 0.86-1.05, P= 0.34). In conclusion the authors show that amoxicillin provides no clinically important benefits in general recovery for the pt with purulent rhinorrhea caused by acute sinusitis. The recommendation by the authors is a patient presenting with acute sinusitis and purulent rhinorrhea can be safely treated

What conclusions/implications for practice were drawn by the authors?

with symptomatic therapy only and be instructed to return for follow up if symptoms persist or worsen. There were no differences in groups of patients receiving amoxicillin vs. a placebo, except the quicker resolve of purulent rhinorrhea. Finding states with or without treatment with amoxicillin complaints last long and a failure to prescribe antibiotics is safe.
Your Critical Appraisal of the Studys Appropriateness for Application to Clinical Practice Was the research design appropriate for the research question (e.g., RCT for cause-effect The research design (double-blind randomized placeboquestions, Case Control for harm or causation controlled trail) was appropriate for answering the intervention questions, Cohort for questions regarding and effectiveness question. The RCT offer best evidence at a prognosis)? Support your response.

Was the sample size adequate? Was bias controlled with sample selection methods? Support your responses.

Were the study results significant (level of significance)? Are the results valid and reliable? Is there a possibility of bias or of confounding variables? Support your responses.

Is the study and its findings directly applicable to your EBP question (match all selection criteria)? Support your response.

level 2 in the evidence hierarchy of designs because of its inclusion in meta-analysis (Young, et al., 2008) which is a level 1 in the hierarchy. Yes, the sample size was adequate and large for the question of most effective treatment. Despite of the adequate sample size the difference was too small to be statistically significant; however this study has provided clinically significant findings in terms of the EBP question of comparing the effectiveness in improving recovery and reducing symptoms of acute sinusitis. Bias was limited with randomization using a computergenerated random number list, blinding and coding data to protect treatment allocation. The study results were not statistically significant, but clinically significant for the EBP question in regards to the effectiveness in improving recovery and reducing symptoms in patient with acute sinusitis. Results were valid and reliable with CI of 95%. There were no confounding variables that could introduce bias because the inclusion and exclusion criterion was adhered to in sampling and recruitment. There could be a confounding variable r/t pt not taking an optional radiologic examination as offered to estimate the proportion of sinusitis cases. The study finding matches the EBP in terms of population, intervention (antibiotic vs. placebo) and measured outcome (reduced symptoms and improved recovery).

Single Quantitative Study (e.g., Randomized Controlled Trial, Nonrandomized Controlled Trial, CaseControl Study, Cohort Study) Template Citation (APA) Title Database Source (& ID number) Type of Evidence Hierarchical Evidence Rating Level (Garbutt, Banister, Spitznagel, & Piccirillo, 2012) Amoxicillin for Acute Rhinosinusitis: A Randomized Controlled Trial. PubMed (PMID: 22337680) Randomized Controlled Trial Level II

Your Summary of the Study/Publication (use paraphrasing, not quotes) What was the stated research To determine the incremental effect of amoxicillin treatment question/objective of the study? over symptomatic treatments for adults with clinically What research methodology was used (e.g., RCT, Case-Control, Cohort)? Describe the sample (including size)?

diagnosed acute rhinosinusitis. Randomized, placebo-controlled trial. (level 2) Adults Dx with uncomplicated acute rhinosinusitis. n=166 adult patients (n=85 randomized to receive amoxicillin, n=81 randomized to receive placebo) After a full 28 day trial (n=81 amoxicillin group; n=74 placebo group). The sample was selected from 10 offices of primary care physicians in St. Louis, Missouri. Randomization, computergenerated random numbers, and blocked randomization.

How was the sample selected (e.g., randomization, inclusion/exclusion criteria)?

What methods were used for data analysis?

What were the results of the study? At what Level of Significance?

Inclusion criteria: 18-70 yrs of age who met the CDC and preventions expert panels diagnostic criteria for acute bacterial rhinosinusitis. Symptoms that were moderate, severe, or very severe were deemed eligible. Diagnosis required history of maxillary pain or tenderness in face or teeth, purulent nasal secretions, and rhinosinusitis symptoms for 7 days or more and 28 days or less that were not improving or worsening, or rhinosinusitis symptoms lasting for less than 7 days that had significantly worsened after initial improvement. Exclusion criteria: If patient had an allergy to penicillin or amoxicillin, prior antibiotic treatment within 4 weeks, complications of sinusitis, a comorbidity that may impair their immune response, cystic fibrosis, required an antibiotic for a concurrent condition, were pregnant, or rated their symptoms as very mild or mild. Analysis of Variance ANOVA, X2 test or Fisher exact test, logistic regression, and statistical analyses using SAS version 9.12. No statistical significant results were noted, all p>0.05 with regards to mean change similar in day 3 and day 10 of treatment, days missed, and symptom improvement, exception was mean of symptom improvement was greater in amoxicillin group on day 7 P=0.02. The statistically significant benefit from result of day 7 was too small to represent and clinically important change in practice. Also reported 2 tailed P value <0.05 for statistical significance for intention to treat principle. Disease-specific quality of life: The mean change in SNOT-16 was similar in both groups at day 3 (amoxicillin group: 0.59 [95% CI, 0.470.71]; control group: 0.54 [95% CI, 0.41-0.67], p= .69; mean difference between groups, 0.03 [95% CI, -0.12 0.19]) and at day 10 (mean difference between group, 0.01 [95% CI, -0.13-0.15]. but differed at day 7, favoring amoxicillin (mean difference between groups of 0.19 [95% CI, 0.024- 0.35]). Days missed from work or unable to perform usual activities, rates of relapse and recurrence by 28days additional health care use, and satisfaction with treatment did not differ by study groups. Telephone calls to the MD (5% for amoxicillin group and 10% for control group; P=.35) and additional office visits (2% for amoxicillin group and 4% for control group; P=.66). Symptom change: No statistically significant difference in reported symptom improvement at day 3 (37% amoxicillin group vs. 34% control group; P= 0.67) or on day 10 (78% amoxicillin group vs. 80% control group, P=0.71),

What conclusions/implications for practice were drawn by the authors?

although on day 7 more patients in the amoxicillin group reported symptom improvement (74% amoxicillin group vs. 56% control group, P=0.02). No adverse events occurred. The only symptom that predicted benefit with antibiotic treatment at 7 day was nasal obstruction (n=83) the odds of improvement by day 7 with antibiotic treatment vs. placebo was 4.59 (95% CI, 1.16-18.12) with no benefit in the group without obstruction. Conclusion: Patients Dx with acute rhinosinusitis given a 10 days course of antibiotics compared to a placebo there was no difference in reducing symptoms at day 3 of treatment. The intent of this study was to evaluate the CDC clinical guidelines in the community setting, determining the effectiveness of amoxicillin compared to symptomatic treatment for pts. with clinically diagnosed acute rhinosinusitis. The study results support recommendations to avoid routine antibiotic treatment for pts. with uncomplicated acute rhinosinusitis. There were no statistically significant differences between groups on day 3 and day 10. The statistically significant benefit from result of day 7 was too small to represent any clinically important change in practice or deviation from the recommended guidelines of the CDC. No serious adverse effects occurred.

Your Critical Appraisal of the Studys Appropriateness for Application to Clinical Practice Was the research design appropriate for the The research design (Randomized Controlled Trial) was research question (e.g., RCT for causeappropriate for answering intervention/effectiveness question. effect questions, Case Control for harm or A better design would be an inclusion in a system analysis or causation questions, Cohort for questions meta-analysis. One could use this same question posed by this regarding prognosis)? Support your study in a meta-analysis design with other RCTs. response. Was the sample size adequate? Was bias The sample size was adequate for the EBP question controlled with sample selection methods? demonstrating the effective treatment to be prescribed for acute Support your responses.

sinusitis. No improvement shown between group differences on day 3 or day 10, reflecting that there is no difference in treatment choices or benefits from antibiotic therapy until s/s persists past days 7-10. The authors had estimated needing a sample of 100 participants per treatment group for a provided power of 83% to detect a true difference of 0.25 in the SNOT16 scores on day 3. There was limited bias in sample selection. Randomization was used in advance by the investigational pharmacist that did not participate in the studys enrollment or outcome assessment. Blocked randomization was use by a computer-generated random numbers determining how the two interventions (antibiotic and placebo) were allocated to the consecutively numbered study treatment packages (blinding) to eliminate selection and intervention biases.

Were the study results significant (level of significance)? Are the results valid and reliable? Is there a possibility of bias or of confounding variables? Support your responses.

Is the study and its findings directly applicable to your EBP question (match all selection criteria)? Support your response.

The study results were not statistically significant; clinically significant for the EBP question in regards to choose of treatment and effectiveness in reducing symptoms and improving recovery in pts. with acute sinusitis. Clinicaly significant because this study supports the CDC recommendation for treatment of acute sinusitis in adults. Results are valid and reliable with CI of 95%. There no probability of bias. The inclusion and exclusion criteria limit confounding variables, as well the sampling method and research design limiting bias. There is one possible confounding variable of possible inadequate dose of amoxicillin related to the possibility of amoxicillin-resistant s. pneumonia in the community, but the authors of this study state that prevalence was low. The study matches the EBP question in terms of population (patients diagnosed with acute sinusitis) and intervention (antibiotic treatment compared to placebo treatment) with outcome being the reduction of symptoms and improved recovery with 7-10 day period. The findings are clinically significant in terms of EBP and supported CDC guidelines to effectively stimulate clinical practice changes. These findings assist in reduction of antibiotic prescribing and overuse of antibiotics to reduce the progression of amoxicillin-resistance s pneumonia in the patient population.

Meta-Analysis Template Citation (APA) Title Database Source (& ID number) Type of Evidence Hierarchical Evidence Rating Level (Falagas, et al ., 2008) Comparison of antibiotics with placebo for treatment of acute sinusitis: a meta-analysis of randomised controlled trials PubMed (PMID: 18718440) Meta-analysis of Randomized Controlled Trials Level I antibiotics for acute sinusitis

Your Summary of the Study/Publication (use paraphrasing, not quotes) What was the stated research -To assess the therapeutic role of question/objective of the study? compared with placebo.

What search strategies were used to locate applicable studies for possible inclusion? What were the stated inclusion/exclusion criteria?

-To evaluate existing best evidence (RCTs) of therapeutic benefit of antibiotic Tx vs. placebo in Tx acute sinusitis. All eligible studies used in this meta- analysis were retrieved from PubMed and Scopus. Inclusion criteria: Meta-analysis RCTs selected used a double-blind method that compared Tx. with any antibiotic versus placebo for adult pts.any age with acute sinusitis from

What was the total sample size (e.g., how many studies were included, number of subjects)?

What were the results of the study? At what Level of Significance?

What conclusions/implications for practice were drawn by the authors?

any location. Diagnosis of acute sinusitis in selected RCTs required and determined by either clinical criteria, or a positive radiological, microbiological, or laboratory test in pts. with appropriate clinical manifestations. Included if RCT explicitly stated pt. with clinical diagnosis of acute sinusitis were enrolled. Required sinus like symptoms to be present or not improving after 7 days from onset, or to be worsening after 5 days from onset. RCTs included were in English, Spanish, French, Italian, and German; along with trials presented as abstracts in scientific conferences. RCTs that were included were pts. assessed with mixed types of sinusitis or mixed types of upper respiratory tract infections if data on the subgroup of pts. with acute sinusitis were specifically reported, or if a clinical Dx. of acute sinusitis was supported by more than 2/3 of the study population. Exclusion criteria: All RCTs that did not meet inclusion criteria and patients with no Dx. of acute sinusitis. Adult patients with clinically diagnosed acute sinusitis. 17 double-blind RCTs (3 including children)- 9RCTsDx. With clinical criteria, 6 RCTs Dx with imaging criteria, and 2 RCTs using Dx. microbiological or lab methods criteria. Amoxicillin used in 10 of 23 antibiotic treatment groups. Total outpatient participants 3291 (2915 adults and 376 children) were randomly assigned to receive study treatments in the RCTs or clinical trial selected in the meta-analysis. The use of antibiotics for acute sinusitis confers a small therapeutic benefit over placebo with a corresponding rise in the risk of adverse events. No significant differences were detected in the comparisons between different subgroups of pts. No differences were shown between antibiotic and placebo treatment with regard to disease complications and recurrence. Over all, there were no differences in treatment with antibiotics or placebo with regard in treating acute rhinosinusitis. The authors draw the conclusion that strong evidence is provided that antibiotics are more effective in treating acute sinusitis than placebo. The decision to treat or no to treat with antibiotics is a tradeoff and has a rare risk of developing a disease complication and adverse effect. A clinical decision should be made for pt. that has an assumed acute bacterial sinusitis to treat with antibiotics. Consideration must be given to antibiotic overuse and increasing bacterial drug resistance. The authors could not suggest a universal policy for the prescribing of antibiotics for pts. with acute sinusitis. Identification of patients who are likely to have a bacterial cause for acute sinusitis would benefit from antibiotic

treatment. Further studies are needed to be performed and aimed to better delineate the characteristics of this group of patients.
Your Critical Appraisal of the Studys Appropriateness for Application to Clinical Practice Is the sample size adequate? Support your . This meta-analysis included 17 double-blind RCTs totaling response. 3291 outpatient participants which were an adequate sample

Are the research methods used appropriate for the studys research question/objective? Support your response.

Was the completed search systematic, comprehensive, and without bias? Support your response.

Were selection criteria clearly described? Are they appropriate? Was bias demonstrated in the studys inclusion/exclusion criteria? Support your responses. Is the research recent enough to be applied to current clinical practice? Support your response.

size. However, no significant differences were shown between groups to justify a practice change to Tx. with antibiotics prior to a 7-10 day period of s/s of acute sinusitis. The conclusion by the authors is that this study presents strong evidence that antibiotic treatment in more beneficial to patient Dx. with acute sinusitis. A difference may have been seen with a larger sampling size in some of the RCTs chosen. The research methods and review of RCTs for inclusion were appropriate for the studys stated objective. The 17 RCTs chosen reflected a no difference of treatment between groups. There were no therapeutic benefits in use of antibiotic Tx. for acute sinusitis with a 7-10 day of the present symptoms in comparison to no treating with antibiotics. The inclusion of the RCTs in this meta-analysis show use of best evidence including trials with a double-blind method that compared treatment with any antibiotic versus placebo for patients of any age and in any location. Patient must has had a diagnosis of acute sinusitis required to be determined by either clinical criteria or positive radiological, microbiological or laboratory test with appropriate clinical symptoms. This meta-analysis used a complete search systematically and was comprehensive without bias. Reviewed and screened RCTs were on the basis of title and abstract. An inclusion criterion was used and consistent. Data extraction was performed by two investigators independently extracted and tabulated. Differences between the two investigator reviewers were resolved in meeting with all investigators without bias. The selection criteria were clearly stated in the study and were appropriate. Bias was not demonstrated in the studys inclusion or exclusion criteria. Determined by two investigators independently to avoid bias of selection and to meet set criteria for inclusion. Of the 17 RCTs used in the meta-analysis of 2008, 6 RCTs were conducted within 5 yrs of this study, 4 RCTs were conducted within 10 yrs of the study, and 7 RCTs were conducted later than 10 yrs. Given that the majority of the RCTs chosen were conducted and published with 10 yrs of this conducted meta-analysis the conclusion is that the research is current for clinical practice. RCTs data present and evaluated has impact on clinical practice.

Were the study results significant (level of significance)? Support your response.

Is the study and its findings directly applicable to your EBP question (match all selection criteria)? Support your response.

Yes, the study results were significant to clinical practice. The meta-analysis presented states that it provides strong evidence that antibiotic treatments are more effective to Tx. pts. with acute sinusitis then a placebo, the presumption is that the pt. has an acute bacterial sinusitis. Although, there was no significant differences between subgroup of pts. in comparisons or no differences shown between antibiotic and placebo Tx. with regard to disease complications and recurrence. Little if no differences were found to be significant in prescribing an antibiotic for acute sinusitis symptoms when the clinical assessment and diagnosis cannot be confirmed between viral or bacterial infections. Therefore, decreasing antibiotic use and decreasing potential antibiotic resistance as well as using clinical judgment in being reluctant to prescribe antibiotics immediately will assist in the diagnosis of viral vs bacterial acute sinusitis by unresolved symptoms between 7-10 days would be more appropriate within clinical practice and adheres to the current CDC guidelines in the USA pertaining to Tx. of acute sinusitis. No significance level was specifically stated. This meta-analysis and it inclusion of RCTs within this study, it is directly applicable to my EBP question. This study represents RCTs comparing antibiotic treatment vs. placebo for effectiveness of reducing or improving symptom within 710day in patient with acute sinusitis. The RCTs within the meta-analysis directly represents the population of interest, independent variable and outcome in my PICOT. By reducing the over use of antibiotic treatment and decreasing future potential development of antibiotic resistance that may develop later in unresolved or complicated acute sinusitis of bacterial origin within patients. The adverse effects of waiting to prescribe antibiotics is not generally of a severe degree or serious disease complications are rare.

Meta-Analysis Template Citation (APA) Title Database Source (& ID number) Type of Evidence Hierarchical Evidence Rating Level (Young, et al., 2008) Antibiotics for adults with clinically diagnosed acute rhinosinusitis: a meta-analysis of individual patient data. PubMed (PMID: 18342685) Meta-analysis of individual patient data Level I

Your Summary of the Study/Publication (use paraphrasing, not quotes)

What was the stated research question/objective of the study?

-To evaluate best evidence available in RCTs. in assessing the whether common signs and symptoms can be used to identify a subgroup of patients who benefit from antibiotic treatment for acute rhinosinusitis. -To assess the overall effect of antibiotic treatment and the prognostic value of common signs and symptoms by the number needed to treat (NNT) with antibiotics to cure one additional patient. Searching the Cochrane Central Register of Controlled Trials, Medline, and Embase, and reference lists of reports describing such trials. Inclusion criteria: RCTs in which adult patients with rhinosinusitis-like complains were randomly assigned to treatment with an antibiotic or a placebo, pts. had to have clinical signs and symptoms of rhinosinusitis, previous common cold or two stages of illness, purulent nasal discharge, unilateral facial pain, toothache, pain when chewing, purulent discharge in the pharynx, or pain on bending. Trials were included in which concomitant medication was part of the trial design, provided the same medication was given to patients in both randomly assigned groups. Exclusion criteria: patients were recruited partly on the basis of results of imaging or laboratory tests or bacterial culture because in a primary care setting such methods are not routinely used or recommended. The sample size totaled 2547 adults (patient data) in 9 trials. Common clinical signs and symptoms cannot identify patients with rhinosinusitis for whom treatment is clearly justified. Antibiotics are no justified even if a patient reports symptoms for longer than 7-10 days. There was no statistical significance reported, but there is a clinical significant in studys findings and being applicable to a family practice. The overall odds ratio for antibiotic treatment effect was 1.37 (95% CI, 1.13-1.66) with a NNT of 15. The presented meta-analysis provide a strong level of evidence against routine or overuse of prescribing antibiotic to treat acute sinusitis in a primary care practice or clinical setting. Pt that are older, symptomatic longer, or present with more severe symptoms took longer according to the study to resolve, but would not benefit from antibiotic treatment any more than any other patient.

What search strategies were used to locate applicable studies for possible inclusion? What were the stated inclusion/exclusion criteria?

What was the total sample size (e.g., how many studies were included, number of subjects)? What were the results of the study? At what Level of Significance?

What conclusions/implications for practice were drawn by the authors?

The symptoms of previous common cold, tooth pain, unilateral facial pain, pain when bending or purulent rhinorrhea did not have any prognostic value in treatment. Note purulent drainage to posterior pharynx in exam did have a higher likelihood of antibiotic therapy for treatment and took longer to cure, but results suggest that prognostic value is not sufficient to justify antibiotic treatment in patients with acute sinusitis. This study support CDC guidelines for treatment of acute sinusitis if symptoms present for longer than 7-10 days. Also NNt was 15, so 15 pts. have to be treated for one additional patient to be cured. On a larger scale NNT of 15 is too costly and consideration of complications of over prescribing antibiotics in the clinical setting.
Your Critical Appraisal of the Studys Appropriateness for Application to Clinical Practice Is the sample size adequate? Support your The study stated the use of 9 RCT with a total of 2547 response. individual patient data which is adequate as a sample Are the research methods used appropriate for the studys research question/objective? Support your response.

Was the completed search systematic, comprehensive, and without bias? Support your response.

Were selection criteria clearly described? Are they appropriate? Was bias demonstrated in the studys inclusion/exclusion criteria? Support your responses.

Is the research recent enough to be applied to current clinical practice? Support your response.

size. The research methods used were appropriate for the studys research objective. It identified NNT number of 15. The study did not identify a subgroup for which treatment with antibiotics was clearly justified. Antibiotics were no justified in treatment of acute sinusitis ever if the patient reports symptoms for longer than 7-10 days, the severity of symptoms are only relevant if presenting with serious complications than immediate antibiotic therapy may be provided. These result answer and meet the authors objected in the study. The search was complete and systematic, it did no show that the researchers use bias in selecting articles for this study. The use of multi resources in searching for best evidence in trials for this study was used. Articles that were selected span between 1997 to 2007. They used a protocol registered with the Cochrane Collaboration for conducting a systematic search. Yes, the selection criteria were clearly described by the author and were appropriate. No bias was demonstrated in the study in relationship to the inclusion/exclusion criteria because the criteria were based on clinical assessment and observation, no diagnostic data was used for criteria. Also the individual patient data were checked and reanalyzed for each participant in all 9 trials and checked by protocol. This researcher referenced approximately 8 meta-analysis and one systematic review. Of the 9 RCTs use in this study published in 2008 , used RCTs spanning from

Were the study results significant (level of significance)? Support your response.

Is the study and its findings directly applicable to your EBP question (match all selection criteria)? Support your response.

1997 to 2007, 1 RCT published in 2007 within 5 yrs. If 2012, 7 RCTs published from 2002 to 2005, and 1 RCT published in 1997. Yes, the research can be applied to current clinical practice and support current CDC guideline for treatment for acute sinusitis. Yes, the results of the study are significant to clinical practice, although results are no applicable to children. This study is significant because it verifies the CDC guideline of best practice and support the treatment recommendation for acute sinusitis, a well as meeting the objective of NNT. Yes the study finding at directly applicable to my EBP question and matches the selection criteria of intervention (antibiotic treatment compared to a placebo) for an effective outcome (reduced symptoms and improved recovery) within the patient( population) diagnosed with acute sinusitis. The study finding answers the question by stating that antibiotics are not justified even if a patient reports symptoms for longer 7-10days.

References Bucher, H. C., Tschudi, P., Young, J., Periat, P., Welge-Lussen, A., Zust, H., BASINUS investigators. (2003, Aug). Effect of Anoxicillin-Clavulanate in Clinically Diagnosed Acute Rhinosinusitis: A Placebo-Controlled, Double-blind, Randomized Trial in General Practice. Archives Internal Medicine, 163, 1793-1798. CDC. (n.d.). Get Smart: Treatment Guidelines for Upper Respiratory Tract Infections. Retrieved November 3, 2012, from Centers for Disease Contol and Provention: http://www.cdc.gov/getsmart/resources/related-programs.html

De Sutter, A. I., De Meyere, M. J., Christiaens, T. C., van Driel, M. L., Peersman, W., & De Maeseneer, J. M. (2002, April). Does Amoxicillim Improve Outcomes in Patients with Purulent Rhinorrhea? A Pragmatic Randomized Double-blind Controlled Trial in Family Practice. The Journal of Family Practice, 51(4), 317-323. Falagas, M. E., Giannopoulou, K. P., Vardakas, K. Z., Dimopoulos, G., & Karageorgopoulos, D. E. (2008, September). Comparison of antibiotics with placebo for treatment of acute sinusitis: a meta-analysis of randomised controlled trials. The lancet, 8, 543-552. Garbutt, J. M., Banister, C., Spitznagel, E., & Piccirillo, J. F. (2012, February 15). Amoxicillin for Acute Rhinosinusitis: A Randomized Controlled Trial. Journal of American Medical Association (JAMA), 307(7), 685-692. Jacobs, R. F. (2000, September). Judicious use of antibiotics for common pediatric respiratory infections. Pediatrics Infectious Disease Journal, 19(9), 938-943. Melnyk, B. M.-O. (2011). Evidence-Based Practice in Nursing & Healthcare. New York: Lippincott Williams & Wilkens. Polit, D. F. (2012). Nursing Research Generating and Assessing Evidence for Nursing Practice. New York: Lippincott Williams & Wilkins. Young, J., De Sutter, A., Merenstein, D., vanEssen, G. A., Kaiser, L., Varonen, H., . . . Bucher, H. C. (2008, March 15). Antibiotics for adults with clinically diagnosed acute rhinosinusitis: a meta-analysis of individual patient data. The Lancet, 371, 908-914.